DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a 35 USC 371 National Stage filing of international application PCT/US2021/022375, filed March 15, 2021, which claims the benefit of an effective US filing date from provisional applications 63/120,091 and 63/025,775, filed December 1, 2020 and May 15, 2020, respectively.
Information Disclosure Statement
The information disclosure statements dated November 15, 2022, May 22, 2023 and August 2, 2023 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election of the invention of Group I, drawn to compounds of the formula (I), in the reply filed August 26, 2025 is acknowledged. Further, Applicant’s election of the compound
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as the species of Formula (I), in the same reply is also acknowledged. Applicant contends that the elected species reads on claims 1, 17 and 36 within the elected group.
The requirement is still deemed to be proper and is made final.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: no prior art was discovered over the elected species. Accordingly, the scope of the search and consideration was expanded beyond the elected species to also include the compounds described in the prior art rejection herein.
Status of Claims
Currently, claims 1-17 and 36-38 are pending in the instant application. Claims 2-16 and 37-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 1, 17 and 36 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 17 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20170313685 (“the ‘685 publication”).
Regarding claim 1, the ‘685 publication teaches compounds of the formula
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(paragraph [0009]) and teaches anticipatory compounds reading on the instantly claimed formula throughout the reference. Further, pharmaceutical compositions of the prior art compounds are taught, for example, at paragraph [0064] and claim 19 of the prior art. The anticipatory compounds with respect to the formula of instant claim 1 are as follows: All compounds in Tables 1A-1C (paragraph [0105]). As one example of particular relevance over the instant claims, the prior art teaches compound 77 (paragraph [0220], FIG. 5C, claim 18). The anticipatory compound reads on instant Formula (I) where X1 and X2 are each O; R1 is cyclohexyl; R2 is imidazolyl (reads on R2=aryl or R2=heterocyclyl); R3 is pyridyl (reads on R3=aryl or R2=heterocyclyl); and R4 is t-butylphenyl. Further, the prior art compound is the same as one specifically recited by structure in instant claim 17 (Page numbered 5 of the instantly examined claim set). Thus, since the prior art teaches all required features of the instantly claimed invention, the claims are anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 17 and 36 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-18 of US Patent 9,975,885.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the compound and compositions used in the instantly claimed methods are anticipated by those in the patented claims. In particular, the conflicting claims recite compounds of the formula
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, pharmaceutical compositions (claim 15), and methods of treatment comprising administration of the compound (claims 16-18). The conflicting claims overlap with the instant claims where R4 is phenyl and R2 is imidazole. By way of particular examples, many anticipatory compounds are claimed in the conflicting patent, including
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and
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(see patented claim 14).
The compounds exemplified above read on instant Formula (I) where X1 and X2 are each O; R1 is cyclohexyl or cyclopentyl; R2 is imidazolyl (reads on R2=aryl or R2=heterocyclyl); R3 is pyridyl (reads on R3=aryl or R2=heterocyclyl); and R4 is t-butylphenyl.Since the patented claims encompass all the required features of the instant claims, a double patenting rejection is appropriate.
Claims 1, 17 and 36 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9 of US Patent 9,975,885.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the compound and compositions used in the instantly claimed methods are anticipated by those in the patented claims. In particular, the conflicting claims recite compounds of the formula
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(IIIb) or
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(IIIc), and pharmaceutical compositions (claim 9). The conflicting claims overlap with the instant claims where R4 is phenyl; R2 is pyrrole; and R1 is alkyl. By way of particular examples, many anticipatory compounds are claimed in the conflicting patent. In addition to the compounds specifically claimed in conflicting claims 6-8, the patent also teaches the example
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in support of the claimed genus (encompassed by instant Formula (I) and also specifically recited in instant claim 17). The compounds exemplified above read on instant Formula (I) where X1 and X2 are each O; R1 is alkyl; R2 is pyrrolyl; R3 is pyridyl (reads on R3=aryl or R2=heterocyclyl); and R4 is t-butylphenyl. Since the patented claims encompass all the required features of the instant claims, a double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699